HIV/AIDS and InfectionsPhase 2RHIVIERA-02NCT05300035
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
A Phase 2 study testing Recombinant human monoclonal antibody (bNAbs) in people with HIV/AIDS and Infections, run by ANRS, Emerging Infectious Diseases at 17 sites in France.
Trial summary
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV/AIDS and Infections
- What is being tested?
- Recombinant human monoclonal antibody (bNAbs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 17 sitesFrance
- Study dates
- 11 Apr 2024to 10 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed primary HIV-1 infection diagnostic
- Aged ≥18 to ≤70 years old at screening
- Willing to use use an effective method of contraception from the inclusion until the end of the follow-up in the trial
- Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when applicable
- Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit, when applicable
- Informed and written signed consent
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- Participant with regular health insurance
- Willing to accept the trial constraints (travel for IMP administration and ART interruption)
- Willing to be vaccinated against COVID-19 according to recommandations
Who cannot join
- Participation in any other clinical trial requiring additional blood sampling Participation in an observational study without additional blood sampling is permitted
- Participants in whom condom use or PrEP use by the partner will be difficult or impossible
- Pregnant or breastfeeding patient
- Participants under guardianship or curatorship
- Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis active infection History of ischemic heart disease (myocardial infarction, stable or unstable angina, stroke)
- Current or past history of cancer, excluding squamous cell skin cancers
Show all 17Show fewer
- History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic neuropathy)
- Any medical condition that contraindicates ART interruption
- Concomitant or previous conditions that preclude injection of monoclonal antibodies
- History of systemic corticosteroids, immunosuppressive and anti-cancer medications within the last 6 months
- History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions
- Individuals with any contraindication (including hypersensitivity reaction) to 3BNC117-LS and 10-1074-LS infusion
- Prothrombin < 50%
- Creatinine clearance < 60mL/mn (Cockroft)
- ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of normal
- Patient with an isolated HIV-2 viral strain
- Planned absence that could affect participation in the trial (travel abroad, relocation, impending transfer...)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
Hôpial Avicenne - SMIT
Bobigny, 93000
Brigitte Gbaguidi, brigitte.gbaguidi@aphp.fr
Olivier Bouchaud
- Recruiting
Hôpital Antoine Béclère
Clamart, 92140
Sandrine Poirier, sandrine.poirier@aphp.fr
Sophie Abgrall
- Recruiting
Hôpital Beaujon - Service de médecine interne
Clichy, 92110
Abdelmoula Becharef, abdelmoula.becharef@aphp.fr
Agnès Villemant Ululag
- Recruiting
CHI Créteil - HdJ
Créteil, 94010
Laurent Richier, laurent.richier@chicreteil.fr
Valérie Garrait
- Recruiting
Hôpital Raymond Poincaré - SMIT
Garches, 92380
Rezak Mahrez, rezak.mahrez@aphp.fr
Pierre De Truchis
- Recruiting
Hôpital Bicêtre - HdJ - Médecine interne
Le Kremlin-Bicêtre, 94275
Véronique Godard, veronique.godard@aphp.fr
Cécile Goujard
- Recruiting
Hôpital Hôtel - Dieu
Paris, 75004
Marie-Josée Dulucq, marie-josee.dulucq@aphp.fr
Jean-Paul Viard
- Not yet recruiting
Hôpital Hôtel Dieu - Service d'immunologie clinique
Paris, 75004
Anne Rachline, anne.rachline@aphp.fr
Laurence Weiss
- Recruiting
Hôpital Pitié-Salpêtrière - SMIT
Paris, 75013
Yasmine Dudoit, yasmine.dudoit@aphp.fr
Naima Hamani, naima.hamani@aphp.fr
- Recruiting
Hôpital Lariboisière - Service de médecine interne A
Paris, 75475
Guylaine Alexandre, guylaine.alexandre@aphp.fr
Pierre Sellier
- Recruiting
Hôpital Saint- Louis - SMIT
Paris, 75475
Cylia Imekhlaf, cylia.imekhlaf@aphp.fr
Caroline Lascoux-Combe
- Recruiting
Hôpital Saint-Antoine - SMIT
Paris, 75571
Bénédicte Lefebvre, benedicte.lefebvre2@aphp.fr
Julie Lamarque, julie.lamarque@aphp.fr
- Recruiting
Hôpital Necker - SMIT
Paris, 75743
Carole Louisin, carole.louisin@aphp.fr
Claudine Duvivier
- Recruiting
Hôpital Bichat - Claude Bernard - SMIT
Paris, 75877
Lynda Chalal, lynda.chalal@aphp.fr
Jade Ghosn
- Recruiting
Hôpital Tenon - SMIT
Paris, 75970
Pelagie Thibaut, pelagie.thibaut@aphp.fr
Christia Palacios, christia.palacios@aphp.fr
- Recruiting
Centre médico chirurgical Foch - Suresnes
Suresnes, 92151
Amina Fadli, a.fadli@hopital-foch.com
David Zucman
- Recruiting
CHI Villeneuve-Saint-Georges - SMIT
Villeneuve-Saint-Georges, 94195
Laurent Richier, laurent.richier@chiv.fr
Pauline Caraux Paz
About this study
Official title: A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.
Read the detailed description
The study proposes to test an intervention consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS \& 10-1074-LS ) + ART, at primary HIV-1 infection, and to compare it to ART only regarding HIV-1 replication.
The study aims to enrol 69 participants in French (Ile-de-France) clinical centres. Participants will have been diagnosed with primary HIV-1 infection, will start ART during early phase of Primary HIV infection, and will interrupt ART 52 weeks later.
Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound.
- Conditions
- HIV/AIDS and Infections
- Being tested
- Recombinant human monoclonal antibody (bNAbs), Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human monoclonal antibody (bNAbs)Drug
Also called 10-1074-LS and 3BNC117-LS
- Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of bNAbs (3BNC117LS \& 10-1074LS) between Day 7 and Day 10.
- Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions.
- During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks.
- ART resumption, if participant encounters at least one ART resumption criteria.
PlaceboDrug
Also called Saline solution
- Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of placebo (saline solution) between Day 7 and Day 10.
- Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions.
- During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks.
- ART resumption, if participant encounters at least one ART resumption criteria.
| Study group | Role | What they receive |
|---|---|---|
| bNAbs | Active comparator | ART plus dual long-acting (LS) broadly neutralising antibodies (bNAbs) infusion at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI). Receives: Drug: Recombinant human monoclonal antibody (bNAbs) |
| Placebo | Placebo comparator | ART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.
These participants will be considered as post-treatment controllers.
Measured: at Week 24 of antiretroviral treatment interruption period (ATI)
Secondary outcomes (22)
Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)
Number of clinical and biological AE during follow-up. Abnormal laboratory values will be identified as those outside values defined by the DAIDS scale
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Nature and Grade of clinical and biological AE
Grade of clinical and biological adverse during follow-up. The intensity of all AE (serious and non-serious) will be graded using the DAIDS AE Grading Table Corrected Version 2.1-July 2017
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Time of clinical and biological adverse event (AE)
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.
Measured: at Week 24 of antiretroviral treatment interruption period (ATI)
Time to potential ART resumption for non-controllers.
Measured: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption date, assessed up to 48 weeks following ATI
Clinical and immulogical criteria during follow-up: Proportion of participants with clinical symptoms.
Measured: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Clinical and immulogical criteria during follow-up: Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio.
Measured: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Clinical and immulogical criteria during follow-up: Evolution of inflammation markers levels.
physiological parameters levels will be studied: IP10, TGFβ, IL-7, IL-10, IL-12, IL-15, IL-18, Citrulline, sCD14, sCD163, TNF-α
Measured: biological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Immulogical criteria : Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses.
physiological parameters levels will be studied: frequency and functionality of T cells responding to HIV peptides measured by intracellular cytokine staining, surface expression of activation and differentiation markers, HIV suppressive capacity upon co-culture with autologous infected cells
Measured: physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria during follow-up: Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes.
Measured: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ART interruption.
Measured: at Week 12 and Week 24 of antiretroviral treatment interruption period (ATI)
Virological criteria : Cumulative plasma viremia during ART interruption.
Measured: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : in case of ART resumption, time from date of ART interruption begining to date of first HIV-1 RNA ≥ 50 copies/mL
Measured: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : in case of ART resumption, proportion of participant with plasma HIV-1 RNA < 50 copies/mL within 24 weeks of ATI.
Measured: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post- ART interruption evolution.
Measured: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Evolution of detection proportion and level of cell-associated HIV-1 RNA.
Measured: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Qualitative and quantitative changes in the persistent viral reservoir.
physiological parameters levels will be studied: total cell associated HIV-DNA, integrated HIV-DNA, proportion of replication competent vs defective proviruses
Measured: physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Dosages of bNAbs performed during follow-up.
Measured: during ART follow-up (Week 1,Week 12, Week 24, Week 36), and antiretroviral treatment interruption period (Day 0, Week 12, Week 24)
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to use condoms during sexual intercourses
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to have proposed PrEP at their partners.
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Social sciences criteria : Proportion of patients satisfied with their participation and the associated factors
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Social sciences criteria : Impact of the participation in the trial on participant quality of life and quality of sexual life
Through statistical analyses of some self-administered questionnaires items (in particular the SF12.v2 scale for quality of life) and thematic analyses of semi-directive individual interviews we will highlight the impact of the participation in the trial.
Measured: from date of inclusion to the last follow-up visit date, up to 148 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start11 Apr 2024
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS and InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Rockefeller University, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Cécile Goujard, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300035
- Sponsor's protocol ID
- ANRS 176 RHIVIERA-02
- Acronym
- RHIVIERA-02
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.
- ClinicalTrials.gov ID
- NCT05300035
- Acronym / sponsor ID
- RHIVIERA-02 / ANRS 176 RHIVIERA-02
- Conditions
- HIV/AIDS and Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Rockefeller University, Institut Pasteur
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.
Detailed description
The study proposes to test an intervention consisting of dual long-acting HIV-specific broadly neutralizing antibodies (3BNC117-LS \& 10-1074-LS ) + ART, at primary HIV-1 infection, and to compare it to ART only regarding HIV-1 replication.
The study aims to enrol 69 participants in French (Ile-de-France) clinical centres. Participants will have been diagnosed with primary HIV-1 infection, will start ART during early phase of Primary HIV infection, and will interrupt ART 52 weeks later.
Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bNAbs | Active comparator | Drug: Recombinant human monoclonal antibody (bNAbs)ART plus dual long-acting (LS) broadly neutralising antibodies (bNAbs) infusion at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI). |
| Placebo | Placebo comparator | Drug: PlaceboART plus placebo (saline solution) at HIV-1 primary HIV-1 infection, during 52 weeks minimum, followed by and Antiretroviral Treatment Interruption (ATI). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed primary HIV-1 infection diagnostic
- Aged ≥18 to ≤70 years old at screening
- Willing to use use an effective method of contraception from the inclusion until the end of the follow-up in the trial
- Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when applicable
- Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit, when applicable
Key exclusion criteria (17 listed)
- Participation in any other clinical trial requiring additional blood sampling Participation in an observational study without additional blood sampling is permitted
- Participants in whom condom use or PrEP use by the partner will be difficult or impossible
- Pregnant or breastfeeding patient
- Participants under guardianship or curatorship
- Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis active infection History of ischemic heart disease (myocardial infarction, stable or unstable angina, stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human monoclonal antibody (bNAbs)Also: 10-1074-LS and 3BNC117-LS1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of bNAbs (3BNC117LS \& 10-1074LS) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria. | Drug | bNAbs |
| PlaceboAlso: Saline solution1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of placebo (saline solution) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria. | Drug | Placebo |
Primary outcome
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART.
Time frame: at Week 24 of antiretroviral treatment interruption period (ATI)
These participants will be considered as post-treatment controllers.
22 secondary outcomes
Tolerance of bNAbs infusion : Number of clinical and biological adverse event (AE)
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Nature and Grade of clinical and biological AE
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Tolerance of bNAbs infusion : Time of clinical and biological adverse event (AE)
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Proportion of participants resuming ART within the first 24 weeks of ART interruption, according to the reason for resuming.
Time frame: at Week 24 of antiretroviral treatment interruption period (ATI)
Time to potential ART resumption for non-controllers.
Time frame: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption date, assessed up to 48 weeks following ATI
Clinical and immulogical criteria during follow-up: Proportion of participants with clinical symptoms.
Time frame: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Clinical and immulogical criteria during follow-up: Evolution of CD4, CD8 (levels and %) and CD4/CD8 ratio.
Time frame: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Clinical and immulogical criteria during follow-up: Evolution of inflammation markers levels.
Time frame: biological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Immulogical criteria : Changes in the magnitude and quality of HIV-specific T cell responses and humoral responses.
Time frame: physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria during follow-up: Plasma HIV-1 RNA and HIV-1 DNA level and cell-associated HIV RNA transcripts changes.
Time frame: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Proportion of participant with plasma HIV-1 RNA < 50 cp/mL at 12- and 24-weeks following ART interruption.
Time frame: at Week 12 and Week 24 of antiretroviral treatment interruption period (ATI)
Virological criteria : Cumulative plasma viremia during ART interruption.
Time frame: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : in case of ART resumption, time from date of ART interruption begining to date of first HIV-1 RNA ≥ 50 copies/mL
Time frame: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : in case of ART resumption, proportion of participant with plasma HIV-1 RNA < 50 copies/mL within 24 weeks of ATI.
Time frame: from Day 0 of antiretroviral treatment interruption period (ATI) to Day 0 of ART resumption, assessed up to 48 weeks following ATI
Virological criteria : Evolution of total HIV-1 DNA and cell-associated HIV-1 RNA by US q-PCR and predictive value on post- ART interruption evolution.
Time frame: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Evolution of detection proportion and level of cell-associated HIV-1 RNA.
Time frame: during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Virological criteria : Qualitative and quantitative changes in the persistent viral reservoir.
Time frame: physiological parameters levels during all ART period (from Day 0 to Week 52 ARV), during all ATI period (from Day 0 ATI to Day 0 ART Resumption) and during ART resumption period (from Day 0 to Week 24 ART Resumption)
Dosages of bNAbs performed during follow-up.
Time frame: during ART follow-up (Week 1,Week 12, Week 24, Week 36), and antiretroviral treatment interruption period (Day 0, Week 12, Week 24)
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to use condoms during sexual intercourses
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Criteria related to the risk of HIV-1 transmission : Proportion of participants reporting to have proposed PrEP at their partners.
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Social sciences criteria : Proportion of patients satisfied with their participation and the associated factors
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Social sciences criteria : Impact of the participation in the trial on participant quality of life and quality of sexual life
Time frame: from date of inclusion to the last follow-up visit date, up to 148 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cécile Goujard, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human monoclonal antibody (bNAbs) in people with HIV/AIDS and Infections, run by ANRS, Emerging Infectious Diseases at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Ghislain, MSc (+331 45 59 52 29, mathilde.ghislain@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART. (time frame: at Week 24 of antiretroviral treatment interruption period (ATI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.